MEDICAL DEVICES

 

Most Class II (moderate risk) Medical Devices require a Premarket Notification 510(k) clearance from the FDA before they may be legally marketed

 

Medical Devices

$350.00

Before you export your medical device to the United States, register your company with the U.S. Food and Drug Administration, to avoid the detention of your shipment.

Click here for additional information. You may also use the Live Support Chat for any question, 24/7.

We expect you to provide the following with your payment:

  • Full company name, complete physical address (street, city, state, postal code, country)
  • Company DUNS Number
  • Name, telephone and email of CEO / Manager
  • Products details
FDA REGISTRATION
LOW ANNUAL SERVICE | FEES

LIMITED
OFFER

$350.00

U.S. Agent Service included.

Bringing medical devices to the U.S. market may appear complex. FDA Premarket Notification 510(k) demonstrates that a medical device is “substantially equivalent” to an approved device. The latter is commonly referred to as the “predicate device” or “predicate”.